Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2025-12-16 @ 7:10 PM
Study NCT ID:
NCT04608851
Status:
None
Last Update Posted:
2022-07-06 00:00:00
First Post:
2020-10-28 00:00:00
Brief Title:
Preventing Urinary Tract Infections With E. Coli Nissle:
Sponsor:
University of Oulu
Organization:
University of Oulu
Study Overview
Official Title:
Preventing Urinary Tract Infections in Infants and Young Children With Probiotic E. Coli Nissle:
Status:
None
Status Verified Date:
2022-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FinNissle
Brief Summary:
In order to asses efficacy of E. coli Nissle strain in prevention of recurrent UTIs in children, we aim to conduct randomized, placebo controlled and double blinded clinical trial. We are going to recruit children who are suffering the first urinary tract infection of their life. The UTI will be treated by normal clinical recommendations decided by treating physician. Intervention will start on the day following the last day of the antimicrobial course.
The intervention will last for 15 days and the study participants will receive either intervention drug or placebo. Intervention drug contains 10 E8 CFU/ml of E. coli Nissle strain and will be administered as dose of 1 ml of oral suspension once daily for children aged under one year and twice daily for children aged more than one year.
The study patients will be monitored by monthly electronic surveys for six months after the intervention in order to measure proportion of the children who will have a new UTI during the follow up. We are also going to record possible adverse effects in both study groups. Also use of antimicrobial medication due to any reason will be recorded.
The intervention will last for 15 days and the study participants will receive either intervention drug or placebo. Intervention drug contains 10 E8 CFU/ml of E. coli Nissle strain and will be administered as dose of 1 ml of oral suspension once daily for children aged under one year and twice daily for children aged more than one year.
The study patients will be monitored by monthly electronic surveys for six months after the intervention in order to measure proportion of the children who will have a new UTI during the follow up. We are also going to record possible adverse effects in both study groups. Also use of antimicrobial medication due to any reason will be recorded.
Detailed Description:
In order to asses efficacy of E coli Nissle strain in prevention of recurrent UTIs in children we aim to conduct randomized placebo controlled and double blinded clinical trial We are going to recruit children who are suffering the first urinary tract infection of their life The UTI will be treated by normal clinical recommendations decided by treating physician Intervention will start on the day following the last day of the antimicrobial course
The intervention will last for 15 days and the study participants will receive either intervention drug or placebo Intervention drug contains 10 E8 CFUml of E coli Nissle strain and will be administered as dose of 1 ml of oral suspension once daily for children aged under one year and twice daily for children aged more than one year
The study patients will be monitored by monthly electronic surveys for six months after the intervention in order to measure proportion of the children who will have a new UTI during the follow up We are also going to record possible adverse effects in both study groups Also use of antimicrobial medication due to any reason will be recorded
The intervention will last for 15 days and the study participants will receive either intervention drug or placebo Intervention drug contains 10 E8 CFUml of E coli Nissle strain and will be administered as dose of 1 ml of oral suspension once daily for children aged under one year and twice daily for children aged more than one year
The study patients will be monitored by monthly electronic surveys for six months after the intervention in order to measure proportion of the children who will have a new UTI during the follow up We are also going to record possible adverse effects in both study groups Also use of antimicrobial medication due to any reason will be recorded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None